At the beginning of 2016, the Gilead laboratory will submit an application for an extension of the marketing authorization for its antiretroviral drug Truvada for the prevention of AIDS.
- Truvada received a temporary recommendation for use (RTU) on November 25 to prevent HIV infection in people at high risk.
- Two intake schedules are possible: continuous, with a daily tablet, or “on demand”.
- Gilead will file, in the first quarter of 2016, an application for extension of marketing authorization (MA) in HIV prevention.
After the temporary recommendation in France, the authorization in Europe? The Gilead laboratory intends to request an extension of the marketing authorization (MA) for its antiretroviral Truvada (emtricitabine / tenofovir). The dossier should be submitted in early 2016 to the European Medicines Agency (EMA). It aims for a European authorization for pre-exposure prophylaxis (PrEP). The same indication that has just been proven published in a prestigious journal.
France co-rapporteur
Truvada is only authorized for the prevention of HIV infection on a permanent basis in one country: the United States. But “Gilead has confirmed that it is preparing a registration dossier that it should file in the first quarter of 2016.” This was announced by Caroline Semaille, director of anti-infective drugs at the National Security Agency of drug (ANSM), during a press point.
The EMA’s opinion should only be given at the end of 2016. But France will have a major position in the management of the file: it is appointed co-rapporteur alongside the United Kingdom. A strong sign, since this country is at the origin of the other major trial on PrEP, PROUD.
An additional tool
While awaiting European authorization, PrEP benefits from a temporary recommendation for use (RTU) in France. It makes it possible to take Truvada continuously – which will be the preferred scheme – or “on demand” (2 tablets two hours before a risky relationship, 1 tablet 24 hours after, 1 tablet 48 hours after). However, only hospital doctors specializing in HIV treatment will be authorized to establish prescriptions.
The measure is aimed at adults at high risk of acquiring HIV through sexual intercourse, mainly men who have sex with men (MSM). On a case-by-case basis, hospital physicians may also prescribe Truvada to heterosexuals at high risk. But “PrEP is authorized as an additional tool in a diversified prevention offer,” said Caroline Semaille.
Close monitoring
Within the framework of the RTU, a strict follow-up of the patients will be carried out. During the initiation visit, the doctor will have to check several biological elements – including kidney function – and behavior. A first follow-up visit will be imposed at one month, then one every three months, including mandatory HIV testing.
Gilead has also developed an RTU portal, which physicians can securely access. They “will have the protocols of the RTU, will be able to fill in the initiation sheet of the subject,” explains Caroline Semaille. She mentions data such as age, HIV serology, results of laboratory tests, sexual behavior. They are asked to collect a certain amount of information both behavioral and biological. ”
And unlike the Baclofen portal, which has experienced a real flop, hospital doctors should rather comply with these procedures. The ultimate complement to this monitoring arsenal, the National AIDS Research Agency (ANRS) will launch a monitoring study in order to complete the data collected within the framework of the RTU.
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